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Clinical Trials/NCT05538351
NCT05538351
Active, not recruiting
Not Applicable

A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury

University of Hertfordshire1 site in 1 country120 target enrollmentSeptember 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
University of Hertfordshire
Enrollment
120
Locations
1
Primary Endpoint
To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI.
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment.

Detailed Description

Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment. Aim: To develop an Enhanced Fluid Assessment Tool for patients with AKI. Workstream 1: Aim: To identify what methods are useful to assess fluid in a patient with AKI. The fluid assessment techniques that are useful and are used, bioimpedance and patient reported signs and symptoms. Workstream 2: Aim: To identify the best methods of determining fluid status in a patient with AKI The findings from Workstream 1 will be used to rank the most useful fluid assessment techniques. This will lead to the development of the enhanced fluid assessment tool. Workstream 3: Aim: To assess if the tool is practical and clinically useful in determining a patient's fluid status. The terminology and language will be reviewed and the tool will be used to assess patients and to determine the patients fluid status.

Registry
clinicaltrials.gov
Start Date
September 9, 2022
End Date
August 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Hertfordshire
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Workstream 1 and 3 (phase 3):
  • Patients who will be included in the study will be Adult patients (over 18 years old) identified as having an acute kidney injury (AKI) within 72 hours of admission to hospital.
  • Workstream 2:
  • Experts in fluid assessment (Doctors, Nurses and AHPs). Persons included will be experts in their field of practice and have a recognised expertise in fluid assessment.
  • Workstream 3:
  • Phase 1: Experts in fluid assessment (Doctors, Nurses and AHPs). Phase 2: Staff nurses currently working on a clinical ward.

Exclusion Criteria

  • Patients who have kidney failure requiring dialysis or who are being conservatively managed.
  • Patients who are receiving end of Life (EoL) care.
  • Patients who have a pacemaker as this interferes with bioimpedance (WS1+3).
  • There is no baseline creatinine.
  • The patient has acquired an AKI 72 hours after admission to hospital.
  • The patient has acute coronary syndrome

Outcomes

Primary Outcomes

To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI.

Time Frame: Within 72 hours of admission

Identifying the components of a volume assessment as defined in RCP (2015) Acute care toolkit and a scoping review on fluid assessment. Assessment includes; physiological parameters including blood pressure, weight changes, and physical examination, including identifying any signs of oedema or dehydration and history taking.

Secondary Outcomes

  • To evaluate whether fluid status of patients is related to: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements(At 30 days after admission)
  • To evaluate whether fluid status is related to: Outcome: Renal Replacement therapy (RRT) during admission/ Recovery of kidney / dialysis dependence at 30 days/ Intensive care admission • Mortality (hospital 30-days) • Readmission (within 30 days)(At 30 days after admission)
  • To identify fluid status of patients with AKI using multiple assessments, including Bioimpedance, objective and subjective clinical assessments.(Within 72 hours of admission)
  • To identify patient-focussed signs and symptoms of hydration in AKI(Within 72 hours of admission)
  • To evaluate whether fluid status of patients is related to: Physical assessment (JVP, oedema, skin, respiratory, lying and standing BP, passive leg raise), Blood results: urea and creatinine, electrolytes, albumin, haemoglobin and bicarbonate.(Within 72 hours of admission)
  • To evaluate whether fluid status is related to: Fluid balance chart/ trends and documentation (positive or negative balance) , Weight trends, Charlson Co-morbidity index(At 30 days since admission)

Study Sites (1)

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